The FDA has been busy this week approving Provenge for use and taking Tylenol to task, it has given InterMune a cold shot. InterMune had previously submitted a drug that was to treat pulmonary fibrosis for approval, and the FDA has turned InterMune down. The drug, which happens to be called pirfenidone, was denied by the Food and Drug Administration because supposedly it had failed to live up to expectations in a second clinical trial. InterMune stock plummeted and investors went scrambling for unsecured loans to get back on board.
InterMune wonder drug is deflated by the FDA
Previously, stocks were soaring for the InterMune corporation. Prices went plummeting as the FDA did not see enough evidence of efficacy in a second trial. For the last few months, the company stock had been on a high, and earlier this week had been trading at $45.44 a share, according the New York Times. InterMune stock went plummeting after word from the FDA losing 80 percent of its value of $36 per share.
Drug is used to treat Pulmonary Fibrosis
Pirfenidone, the drug in question, would have treated symptoms of pulmonary fibrosis, including idiopathic pulmonary fibrosis. Pulmonary fibrosis is a disease which causes scarring and hardening of lung tissue. (Idiopathic means no known cause.) The disease is typically fatal and those who have it generally live only a couple of years after diagnosis. Esbriet would have been the trade name the drug would have been sold under. The article within the Times said the drug postponed death for a short period without slowing any of the symptoms. The benefit would probably be dubious.
Getting back to the drawing board
Numerous felt the FDA should have allowed the drug considering the vicious nature of this disease. This isn’t entirely bad news, as it means that InterMune will likely return to work on the drug. In turn, this may lead to a more effective treatment than pirfenidone, which had only undergone the second round of clinical trials. Even within the first trial it didn’t reverse the disease or damage that was caused.
Resources
New York Times
http://www.nytimes.com/2010/05/05/business/05lung.html?src=busln
